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The following should be helpful in planning, gaining approval for, conducting clinical research and in training research staff.

If you are writing an investigator initiated protocol, please use or reference the protocol template protocol template (58KB, MSWord) to be sure that you address all required elements. The protocol template is designed to ensure your protocol, informed consent documents, and other protocol-related documents are consistent and in compliance with VA requirements.

If the protocol you would like to propose was written by a third party (i.e., the sponsor, the coordinating center, etc.), please use the protocol template to create a local protocol addendum that addresses specifically how the required items will be conducted/addressed at the VA Portland Health Care System (VAPORHCS).

The Cooperative Studies Program offers an excellent tutorial for Good Clinical Practice (GCP). Below are documents courtesy of Cooperative Studies Program Site Monitoring Auditing & Review Team (SMART). Research and Development Service of the VA Portland Health Care System (VAPORHCS) is not responsible for the information within the documents. Information contained in the documents should be used as a guide only. It is the Principal Investigator's responsibility to ensure any documents developed using these tools comply with current VA policies and regulations.

Finally, the audit checklists can assist in assuring you begin research compliant with good clinical practice, VA regulations, and VAPORHCS policies governing human research. You can also use the tools to self-audit any ongoing research and make changes where needed.